FDA UDI
In Commercial Distribution
🇺🇸 United States
ELEDENT
DI: 08435288464718
·
Model: ANTERIOR TEETH D3/E2
·
UNION DENTAL SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELEDENT
- Primary DI
- 08435288464718
- Version / Model
- ANTERIOR TEETH D3/E2
- Catalog Number
- D9D3E2
- Company Name
- UNION DENTAL SA
- Labeler DUNS
- 462114760
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-24
- Public Version
- 1
- Public Version Date
- 2024-10-02
- Public Version Status
- New
- Public Device Record Key
- 1b5ee778-f66c-44be-b24f-b45f0833e54f
Device Description
ELEDENT anterior Teeth Shade D3, Mould E2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELM | Denture, Plastic, Teeth | Dental | 872.3590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38643 | Resin artificial teeth | Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435288464718 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070591 | 000 |